Clinical trial to assess the protective effect of the fixed drug combination of disodium cromoglycate plus reproterol in comparison to the single components and placebo in adults with exercise induced asthma - AERIA

Overview

No summary available.

Registry

who.int

Start Date

July 6, 2007

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\.Female and male subjects aged 18 – 65 years
•2\.Exercise induced asthma with reversible airway obstruction: twice proven EIA defined as maximum decrease in FEV1 against the baseline value of at least 20% (first test results can be obtained during the last 12 months)
•3\.Baseline FEV1 before challenge must be at least 70% of the predicted FEV1
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•Safety concerns:
•1\.Subjects with hypersensitivity to DSCG, reproterol, menthol, peppermint or other excipients of the study medication
•2\.Pregnancy, breast\-feeding or planned pregnancy during the study. Women of child bearing potential not using a highly effective method of birth control defined as those which results in a low failure rate (i.e. \< 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, tubal ligation or vasectomised partner.
•3\. Subjects with an asthma exacerbation within 4 weeks prior to the study start. Asthma exacerbation defined as use of oral (systemic) glucocorticosteroids, unscheduled consultation of a medic due to asthma, hospitalisation, or additional treatment of asthma with antibiotics
•4\. Eosinophilic pneumonia
•5\. Clinically significant cardiovascular diseases (e.g. cardiac infarction, cardiac dysrhythmia, hypertrophic obstructive cardiomyopathy, coronary heart disease...)
•6\. Resting blood pressure over 140/90 mmHg
•7\. Diastolic blood pressure after treadmill\-test over 120 mmHg
•8\. Malignancies including phaeochromocytoma within the last 5 years
•9\. Severe hyperthyreosis, thyreotoxicosis, instable diabetes mellitus